A Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical System

Overview

About this study

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is ≥ 18 years old at time of treatment.
  • Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
  • Written informed consent.

Pre-Operative Exclusion Criteria:

  • Unexplained fever and/or untreated, active infection.
  • Patient pregnancy.
  • Previous head and neck surgery precluding robotic procedures.
  • The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.

Intra-Operative Exclusion Criteria:

  • It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:

    • Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position. 

    • In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Van Abel, M.D.

Open for enrollment

Contact information:

Nicole Tombers R.N., CCRP

(507) 538-1392

Tombers.Nicole@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20207997

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